Category: Candidate

  • Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan

    Shots: Takeda has submitted an NDA to MHLW to import and distribute Moderna’s (mRNA-1273/ TAK-919) in Japan Takeda is conducting a P- I/II study assessing the safety and immunogenicity of two vaccinations of TAK-919 (100μg, given 28 days apart) in 200 participants aged ≥20yrs. followed through 12mos. after the second vaccination. Takeda has completed enrollment […]

  • Covaxx Initiates P-II Trial of UB-612 Against COVID-19 in Taiwan

    Shots: The Taiwan Ministry of Health and Welfare granted conditional approval to initiate P-II trial of UB-612 in 3,850 subjects including adolescents, adults, and seniors across 11 medical centers and hospitals in Taiwan Additionally, Covaxx collaborated with UNMC to conduct clinical trials in the US, and with Dasa S.A. to conduct P-II/III study and distribute […]

  • Clover and Dynavax Plan to Initiate P-II/III Trial for Adjuvanted COVID-19 Vaccine Candidate

    Shots: Clover plans to initiate a global P-II/III efficacy trial with the S-Trimer COVID-19 vaccine candidate adjuvanted with CpG 1018 plus alum in the H1’2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021 Additionally, Clover discontinued their partnership with GSK to evaluate the S-Trimer vaccine candidate with GSK’s pandemic adjuvant […]

  • GSK Presents Results of Maternal & Older Adults RSV Vaccines at IDWeek 2020

    Shots: GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both the candidate vaccines contain a recombinant RSVPreF3, that triggers the required immune response The GSK3844766A was first tested in 48 healthy adults (18-40yrs.) & then in 1005 healthy older adults […]